用于药物研发的数字健康技术（DHTs）
正文 · 中文译文
用于药物开发的数字健康技术（DHTs） 科学与研究专题 数字健康技术 推进监管科学 临床试验与人类受试者保护 关键路径计划 人工智能与医疗产品 FDA的纳米技术项目 新方法学（NAMs） 儿科 科学信息与评估的同行评审 真实世界证据 风险沟通 女性健康研究 数字健康技术（DHTs）在医疗产品（包括药物）的开发中提供了许多潜在益处。DHTs的进步，包括电子传感器、计算平台和信息技术，为直接从患者处获取临床试验数据提供了新机会。可穿戴、植入、吞服或置于环境中的便携式DHTs能够实时收集试验参与者在住所或远离临床试验现场地点的数据。这些DHTs的潜在优势包括能够： 对临床特征进行连续或频繁测量 记录或测量传统研究访视期间无法捕获的新颖临床特征 通过远程获取研究参与者的临床数据来实现临床试验活动的去中心化 FDA致力于支持DHTs在临床药物开发中的应用，并已制定了一项全面的计划，与相关各方在这一重要科学领域开展合作。 《处方药使用者付费法案VII》列出了与药物开发和审评中数字健康技术（DHTs）相关的多项活动，FDA已承诺开展这些活动。这些活动包括： 发布《数字健康技术在药物和生物制品开发中的使用框架》 设立数字健康技术指导委员会 召开公开会议 确定示范项目 《2022年食品和药品综合改革法案》第3606条和第3607条规定了FDA的额外要求，即通过去中心化临床试验和数字健康技术发布关于临床试验现代化的指南。 CDRH数字健康卓越中心旨在赋能利益相关方，通过促进负责任和高质量的数字健康创新来推进医疗保健，该中心还可作为申办方、数字健康技术制造商和其他利益相关方获取数字健康技术相关信息（包括其监管状态）的资源。 《数字健康技术在药物和生物制品开发中的使用框架》 作为我们PDUFA VII承诺的一部分，FDA制定了一个框架，题为《数字健康技术在药物和生物制品开发中的使用框架》。 该计划将包括研讨会和示范项目；与感兴趣各方的接触；建立内部流程以支持对用于药物开发的数字健康技术的评估；促进关于基于数字健康技术的政策、程序和分析工具开发的共享学习和一致性；以及发布指南文件。 数字健康技术指导委员会 作为我们《处方药使用者付费法案七》（PDUFA VII）承诺的一部分，FDA已设立数字健康技术（DHT）指导委员会，该委员会由来自药品评价与研究中心（CDER）、生物制品评价与研究中心（CBER）和器械与放射健康中心（CDRH）的高级职员组成，包括数字健康卓越中心，以及肿瘤卓越中心和临床政策与项目办公室。该指导委员会将支持在药物和生物制品开发中使用DHT的框架实施，以及PDUFA VII承诺函中“加强使用数字健康技术支持药物开发和审评”部分所确定的其他承诺（例如，公开会议、指南文件、示范项目、技术需求、培训）。此外，该指导委员会将监督相关活动，以协助各组织单位采用一致的方法审评包含DHT衍生数据的药物申报资料。进一步而言，该指导委员会将就人体药物开发中与DHT相关的问题与外部相关方接触，并收集有关DHT现状的信息，包括其使用中的具体挑战。 与FDA会面 FDA鼓励考虑在药物开发中使用DHT或开展去中心化临床试验（DCT）的相关方尽早与该机构联系。 点击“与FDA会面”以了解更多关于何时以及如何与FDA接触的信息。 公开会议/研讨会 履行我们的PDUFA VII承诺 到2023财年第二季度末，FDA将召开一系列五场公开会议或研讨会中的第一场，与包括患者、生物制药公司、数字健康技术（DHT）开发者以及学术界在内的关键利益相关方共同讨论，以就DHT在药物和生物制品开发相关监管决策中的使用相关问题收集意见。 2024年6月24-25日：FDA/FNIH数字测量联合研讨会 2023年3月28-29日：理解支持药物开发与审评临床试验的数字健康技术开发优先事项 其他公开网络研讨会 2023年6月20日：SBIA网络研讨会：去中心化临床试验（DCT）指南草案 2022年2月10日：SBIA网络研讨会：远程数据采集数字健康技术指南草案 相关指南 临床研究中用于远程采集的数字健康技术 药物、生物制品和器械的去中心化临床试验 DHT在药物和生物制品开发中使用的框架 临床研究中的电子系统、电子记录和电子签名：问题与解答 包含数字健康内容的指南 资源 指南快照：临床研究中用于远程数据采集的数字健康技术（最终版，2023年12月22日发布）。资源包括关于该指南的快照、回顾播客以及播客文字记录。 PDUFA VII信息技术和生物信息学目标与进展 CDRH数字健康卓越中心 FDA数字健康监管政策 CDER 的药物开发工具（DDT）资格认定项目 新药创新科学与技术方法（ISTAND）项目 CDRH 的医疗器械开发工具（MDDT）资格认定项目 联系信息 如需了解有关用于药物开发的数字健康技术（DHT）的更多信息，请发送电子邮件至 DHTsforDrugDevelopment@fda.hhs.gov。 如需了解有关器械的信息并与数字健康卓越中心联系，请发送电子邮件至 digitalhealth@fda.hhs.gov 内容更新日期： 10/30/2026 受监管产品 药物
正文 · 英文原文
Digital Health Technologies (DHTs) for Drug Development Science and Research Special Topics Digital Health Technologies Advancing Regulatory Science Clinical Trials and Human Subject Protection Critical Path Initiative Artificial Intelligence and Medical Products Nanotechnology Programs at FDA New Approach Methodologies (NAMs) Pediatrics Peer Review of Scientific Information and Assessments Real-World Evidence Risk Communication Women's Health Research Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial data directly from patients. Portable DHTs that may be worn, implanted, ingested, or placed in the environment allow real-time collection of data from trial participants in their homes or at locations remote from clinical trial sites. Potential advantages of these DHTs include the ability to: make continuous or frequent measurements of clinical features record or measure novel clinical features that could not be captured during traditional study visits decentralize clinical trial activities by obtaining clinical data from study participants remotely FDA is committed to supporting the use of DHTs in clinical drug development and has developed a comprehensive program to engage with interested parties in this important scientific area. The Prescription Drug User Fee Act VII has outlined several activities related to DHTs for drug development and review, which FDA has committed to undertake. These activities include: Publishing a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development Establishing a DHT Steering Committee Convening Public Meetings Identifying Demonstration Projects Sections 3606 and 3607 of the Food and Drug Omnibus Reform Act of 2022 outline additional requirements for FDA to publish guidance regarding the modernization of clinical trials through decentralized clinical trials and DHTs. The CDRH Digital Health Center of Excellence, which was established to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation, can also serve as a resource on DHTs, including their regulatory status, for sponsors, DHT manufacturers, and other stakeholders. Framework for the Use of DHTs in Drug and Biological Product Development As part of our PDUFA VII commitment, FDA developed a framework, titled Framework for the Use of DHTs in Drug and Biological Product Development. The program will include workshops and demonstration projects; engagement with interested parties; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. DHT Steering Committee As part of our PDUFA VII commitments, FDA has established the DHT Steering Committee which consists of senior staff from CDER, CBER, and CDRH, including the Digital Health Center of Excellence, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs. The Steering Committee will support the implementation of the framework for the use of DHTs in drug and biological product development as well as other commitments identified in the section “Enhancing Use of Digital Health Technologies to Support Drug Development and Review” of the PDUFA VII commitment letter (e.g., public meetings, guidance documents, demonstration projects, technology needs, training). In addition, the Steering Committee will oversee activities to assist organizational units with consistent approaches to the review of drug submissions that contain DHT-derived data. Further, the Steering Committee will engage with external interested parties on DHT-related issues in human drug development and gather information about the present state of DHTs, including specific challenges in their use. Meeting with FDA FDA encourages interested parties who are considering the use of DHTs in drug development or conducting a decentralized clinical trials (DCTs) to reach out to the agency early. Click on Meeting with FDA to learn more about when and how to engage FDA. Public Meetings/ Workshops Meeting our PDUFA VII Commitment By the end of the 2nd quarter of fiscal year 2023, FDA will convene the first of a series of five public meetings or workshops with key stakeholders, including patients, biopharmaceutical companies, DHT developers, and academia, to gather input on issues related to the use of DHTs in regulatory decision-making related to drug and biological product development. June 24-25, 2024: Joint FDA/FNIH Workshop for Digital Measures March 28-29, 2023: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review Other Public Webinars June 20, 2023: SBIA Webinar: Decentralized Clinical Trials (DCT) Draft Guidance Feb 10, 2022: SBIA Webinar: Digital Health Technologies for Remote Data Acquisition Draft Guidance Related Guidances Digital Health Technologies for Remote Acquisition in Clinical Investigations Decentralized Clinical Trials for Drugs, Biological Products, and Devices Framework for the Use of DHTs in Drug and Biological Product Development Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Guidances with Digital Health Content Resources Guidance Snapshot: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Final, issued 12/22/2023). Resources include a snapshot about the guidance, a recap podcast, and the podcast transcript. PDUFA VII IT and Bioinformatics Goals and Progress CDRH Digital Health Center of Excellence FDA Digital Health Regulatory Policies CDER's Drug Development Tools (DDT) Qualification Programs Innovative Science and Technology Approaches for New Drugs (ISTAND) Program CDRH’s Medical Device Development Tools (MDDT) Qualification Programs Contact Information For more information about DHTs for Drug Development, please email DHTsforDrugDevelopment@fda.hhs.gov. For information about devices and to engage the Digital Health Center of Excellence, send an email to digitalhealth@fda.hhs.gov Content current as of: 10/30/2026 Regulated Product(s) Drugs